Recruiting

Observational Study

Sponsor:

Unity Health Toronto

Code:

NCT04754022

Conditions

Disorder

Heart

Postoperative

Cardiac Surgery

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Restrictive Transfusion Strategy

Liberal transfusion strategy

Study Details

Brief summary:

TRICS-IV is an international, multi-centre, open-label randomized controlled trial of two commonly used transfusion strategies in moderate to high risk patients who are 65 years of age or younger undergoing cardiac surgery on cardiopulmonary bypass, using a superiority trial design.

Conditions

Disorder

Heart

Postoperative

Cardiac Surgery

Study ID

NCT04754022

Start date

Nov 1, 2021

Status verified date

Nov, 2024

Completion date

Jun, 2026

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. ≥18 and ≤65 years of age
2. Planned cardiac surgery using cardiopulmonary bypass
3. Informed consent obtained
4. Preoperative European System for Cardiac Operative Risk Evaluation (EuroSCORE I) of 6 or more

Exclusion Criteria:

1. Patients who refuse participation
2. Patients who are unable to receive or who refuse blood products
3. Patients who are involved in a preoperative autologous pre-donation program
4. Patients who are having a heart transplant or having surgery solely for an insertion of a ventricular assist device
5. Pregnancy or lactation (a negative pregnancy test must be obtained prior to randomization for women of childbearing potential)

Study Design

Enrollment

1440 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Restrictive Transfusion Strategy

Patients will receive a RBC transfusion if their Hb concentration is <75 g/L (<7.5 g/dL; <4.7mmol/L) intraoperatively and/or postoperatively.

active comparator: Liberal Transfusion Strategy

Patients will receive a RBC transfusion if their Hb concentration is <95 g/L (<9.5 g/dL; <5.9mmol/L) intraoperatively, or postoperatively in the ICU; and/or <85 g/L (< 8.5 g/dL; <5.3mmol/L) on the ward.

Interventions

Restrictive Transfusion Strategy

Patients will receive a RBC transfusion if their Hb concentration is <75 g/L (<7.5 g/dL; <4.7mmol/L) intraoperatively and/or postoperatively.

Liberal transfusion strategy

Patients will receive a RBC transfusion if their Hb concentration is <95 g/L (<9.5 g/dL; <5.9mmol/L) intraoperatively, or postoperatively in the ICU; and/or <85 g/L (< 8.5 g/dL; <5.3mmol/L) on the ward.

Primary outcome measure

  • Composite score of any one of the following events occurring 6 months after cardiac surgery: (1) all-cause mortality; (2) myocardial infarction; (3) new onset renal failure requiring dialysis; or (4) new focal neurological deficit (stroke). [ Time Frame: Within 6 months after cardiac surgery. ]

Central Contacts and Locations

Central contacts

David Mazer, MD

416-864-5825David.Mazer@unityhealth.to

Locations

Maine Medical Center

Recruiting

Portland, Maine, United States, 04102

Contacts

Robert Kramer, MD

207-662-2923Robert.Kramer@mainehealth.org

The Cooper Health System

Recruiting

Camden, New Jersey, United States, 08103

Contacts

Ludmil Mitrev, MD

mitrev-ludmil@CooperHealth.edu

University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Contacts

Wing Lam, MD

780-407-8861wingying@ualberta.ca

Interior Health Kelowna General Hospital

Recruiting

Kelowna, British Columbia, Canada, V1Y 0C5

Contacts

Nick Kuzak

250-808-3035nick.kuzak@interiorhealth.ca

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Darren Mullane, MD

604- 875-4304Darren.mullane@vch.ca

Saint John Regional Hospitall

Recruiting

Saint John, New Brunswick, Canada, E2L 4L2

Contacts

Craig Brown

506-648-6102cdbrown@nbnet.nb.ca

Hamilton Health Sciences Centre / Hamilton General Hospital

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Contacts

Richard Whitlock

905-521-2100Richard.whitlock@phri.ca

Health Sciences North Research Institute

Recruiting

Sudbury, Ontario, Canada, P3E 5J1

Contacts

Eugene Leshchyshyn, MD

416-856-8574eugene.leshchyshyn@mail.utoronto.ca

Sunnybrook Health Sciences Center

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Stephen Fremes, MD

416-480-6100stephen.fremes@sunnybrook.ca

St. Michael's Hospital, Unity Health Toronto

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

David Mazer, MD

416-864-5825david.mazer@unityhealth.to

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Matteo Parotto, MD

416-430-5164matteo.parotto@uhn.ca

Montreal Heart Institute

Recruiting

Montreal, Quebec, Canada, H1T 1C8

Contacts

Antoine Rochon, MD

514-376-3330antoine.rochon@icm-mhi.org

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

Matthew Cameron, MD

514-340-8222matthew.cameron@mcgill.ca

Centre hospitalier de l'Université de Montréal

Recruiting

Montréal, Quebec, Canada, H2X 0C1

Contacts

François Carrier

514-890-8444francois.martin.carrier@umontreal.ca

Hôpital Sacré-Cœur de Montréal

Recruiting

Montréal, Quebec, Canada, H4J 1C5

Contacts

Hugues Jeanmart, MD

514-338-2050hugues.jeanmart@umontreal.ca

Institut universitaire de cardiologie et de pneumology de Québec - université Laval (IUCPQ-UL)

Recruiting

Québec, Quebec, Canada, G1V 4G5

Contacts

Étienne J Couture

418-656-8711etienne.couture.3@ulaval.ca

More Information

Sponsor

Unity Health Toronto

Last update posted

Nov 21, 2024

Last verified

Nov, 2024

Keywords

  • Cardiac Surgery
  • Transfusion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2024-11-21.